ACL SNNAP Trial: ACL Surgery Necessity in Non Acute Patients
NCT02980367 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320
Last updated 2021-10-15
Summary
The primary objective of this study is to determine in patients with non-acute Anterior Cruciate Ligament Deficiency (ACLD) whether a strategy of non-surgical management \[Rehabilitation\] (with option for later ACL reconstruction, only if required) is more clinically effective and cost effective than a strategy of surgical management \[Reconstruction\].
Conditions
- Anterior Cruciate Ligament Injury
Interventions
- OTHER
-
Non-Surgical Management (Rehabilitation)
Routine ACL rehabilitation protocols used at the participating site will be followed. As part of the site selection process, documentary evidence of the use of or willingness to adopt a rehabilitation protocol that reflects the guidelines of the mandatory aims/goals set for the study rehabilitation intervention will be required.
- PROCEDURE
-
Surgical Management (Reconstruction)
All surgical reconstructions will be patella tendon or hamstrings tendon depending on the surgeon's preference. All other care will be routine, including immediate post-operative care.
Sponsors & Collaborators
-
University of Oxford
lead OTHER
Principal Investigators
-
David Beard, DPhil · University of Oxford
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-31
- Primary Completion
- 2021-11-30
- Completion
- 2022-03-31
Countries
- United Kingdom
Study Locations
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